New Combination Therapy Brings Hope to Bladder Cancer Patients
A breakthrough in bladder cancer treatment is offering new hope to patients who no longer respond to conventional therapies. The CORE-001 phase 2 clinical trial demonstrated that a novel combination therapy can significantly improve outcomes for patients with Bacillus Calmette-Guérin (BCG)-unresponsive non-muscle invasive bladder cancer.
Bladder cancer affects thousands of people each year, with about 75% of cases diagnosed as non-muscle invasive bladder cancer. Standard treatment involves surgically removing the tumor, followed by BCG immunotherapy. However, nearly half of patients relapse, leaving them with few treatment options and a higher risk of cancer progression.
The CORE-001 trial tested a combination of two therapies: cretostimogene grenadenorepvec, an oncolytic immunotherapy that selectively kills cancer cells, and pembrolizumab, an immune checkpoint inhibitor that helps the immune system combat cancer more effectively. The results have been very encouraging.
"Our combination therapy represents a significant advancement in managing BCG-unresponsive non-muscle invasive bladder cancer," said Roger Li, M.D., principal investigator of the trial and genitourinary oncologist at Moffitt Cancer Center. "Our results indicate that combining cretostimogene grenadenorepvec with pembrolizumab offers a promising, long-term bladder-preserving treatment option for patients with few alternatives."
The trial involved 35 patients. Results presented at the 2024 American Society of Clinical Oncology annual meeting show that over half (57.1%) achieved a complete response at 12 months, meaning no detectable cancer remained in their bladders. Additionally, 82.9% of patients were cancer-free at the three-month mark. Many participants continued to benefit from the treatment, with a median follow-up period of over two years.
"The observed clinical benefits are thought to stem from the synergistic effect of these two therapies," added Li. "This trial's results are encouraging and highlight the potential of combining oncolytic viruses with immune checkpoint inhibitors."
The side effects were manageable and consistent with those seen in other studies of the individual therapies. Most side effects related to cretostimogene grenadenorepvec involved bladder irritation, while pembrolizumab side effects were typical of systemic immunotherapy reactions.
This new approach offers renewed hope to patients who have run out of options, providing a potential path forward that could significantly improve their quality of life and long-term health outcomes.
